BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHILEY

    MDR report key: 840406 · Received April 20, 2007

    Report

    Report Number
    2936999-2007-00177
    Event Type
    Injury
    Date Received
    April 20, 2007
    Date of Event
    April 1, 2007
    Report Date
    April 16, 2007
    Manufacturer
    JUAREZ HENEQUEN
    Product Code
    BTO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON 04/16/2007, THE COMPANY RECEIVED A REPORT, WHERE IT WAS CLAIMED THAT, THE TUBE WAS CHIPPED ON THE INNER RIDGE. THE CALLER REPORTED THAT THIS WAS DISCOVERED DURING PATIENT USE. REPLACEMENT OF THE TUBE WAS REQUIRED. THE CALLER REPORTED TWO OCCURRENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHILEY LOW PRESSURE CUFFED TRACHEOSTOMY BTO JUAREZ HENEQUEN LPC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR